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Shared Decision Making and Autonomy Among US Participants with Multiple Sclerosis in the NARCOMS Registry

Preferences for Multiple Sclerosis Treatments

Exercise is effective for managing symptoms and improving quality of life among people with multiple sclerosis (MS). However, African Americans are underrepresented in MS exercise trials, partly due to limited recruitment resources and avenues tailored to this demographic. This paper describes participant outreach and recruitment strategies for an ongoing, remotely delivered, culturally tailored exercise training program for African American individuals with MS.

Initially, a passive, indirect approach in the form of virtual outreach was employed, distributing study information through MS organizations, local experts, community leaders, patient representatives, and others in the southern United States. The effectiveness of these outreach and recruitment strategies in screening and enrolling was assessed using study coordinator and participant data.

Over 15 months, the outreach methods successfully recruited 80 African Americans with MS into the clinical trial. Following a delayed start and slower initial recruitment, active outreach strategies were incorporated (eg, in-person engagements at local MS events, recreation and community centers, health care facilities, and schools). Additional tactics included study website enhancements, an informational video, email templates, and updates to the study flyer. Most participants (64.9%) were recruited through MS organizations, with virtual platforms (ie, websites, social media; 14.3%) and support groups (9.1%) also contributing to recruitment success.

This study demonstrates the effectiveness of a multipronged, experience-informed approach for successfully enrolling African Americans with MS into clinical trials. While MS organizations proved pivotal for recruiting and enrolling African Americans with MS, leveraging diverse recruitment outlets highlighted the importance of multifaceted strategies for engaging participants from minority backgrounds in research.

From the Department of Health Behavior, The University of Alabama at Birmingham, Birmingham, AL (WNN DP); Department of Kinesiology and Nutrition, The University of Illinois at Chicago, Chicago, IL (DG, VF, RWM); NORC at the University of Chicago, Chicago, IL (EF); Joi Life Wellness Group Multiple Sclerosis Center, Atlanta, GA (MJW); and the School of Kinesiology, University of Michigan, Ann Arbor, MI (DK-H). 

Whitney N. Neal, Department of Medicine, The University of Alabama at Birmingham, 1717 11th Ave S, Birmingham, AL, 35205; 

: wneal@uabmc.edu. Robert W. Motl, PhD, Department of Kinesiology and Nutrition, The University of Illinois at Chicago, 1919 West Taylor St, Chicago, IL, 60612; 

The authors declare no conflicts of interest.

This research is funded through a grant from the Bristol Myers Squibb Foundation (BMSF). All statements in this paper reflect those of the authors and do not necessarily reflect the views of the BMSF.

 The study design and preliminary data from the clinical trial were presented as an oral presentation at the Consortium of Multiple Sclerosis Centers Annual Meeting; May 29-June 1, 2024; Nashville, Tennessee.

Exercise training is highly effective for managing symptoms and improving health-related quality of life among persons with multiple sclerosis (MS),

 yet African American (AA) individuals with MS report lower levels of physical activity participation than White individuals.

 This may, in part, be associated with the observation that the majority of exercise training randomized controlled trials (RCTs) involving people with MS lack information on the race or ethnicity of participants (n = 44, 81%), and in the 9 studies that did collect those data, only 1.7% of participants self-identified as AA.

 There is an absence of evidence of the benefits of exercise training, and rehabilitation broadly, in AA individuals with MS, thereby undermining efforts for behavior change and health promotion.

One potential reason for the limited recruitment and inclusion of diverse samples of people with MS in exercise training RCTs may be that recruitment has often been achieved through a single avenue, typically an MS specialty clinic (84.7%) or an MS organization (13.2%).

 These avenues increase confidence that the people recruited will meet necessary diagnostic criteria for MS, but they may result in limited minority representation based on inequitable health care access across racial and ethnic groups. One review reported that AA and Hispanic people with neurological illnesses, including MS, were less likely to access outpatient neurological care and more likely to seek care in the emergency department compared with their White counterparts.

 Another study observed that AA participants were more likely to cite newspapers or magazines and others with MS as trustworthy sources of research information and less likely to trust universities compared with White participants.

 This suggests that relying on recruitment through MS clinics and organizations alone may impact the diversity of resulting samples.

Effective recruitment of AA participants with MS may require multipronged, nontraditional avenues such as collaboration with nonspecialist community providers and local agencies.

 We are aware of 2 papers involving exercise interventions for people with MS that provide detailed data on multipronged recruitment strategies.

 The papers highlight the use of consultant mail-outs, engagement of clinical partners, and trial awareness strategies; however, neither study described specific strategies for the inclusion of participants from underrepresented groups or included data on the race or ethnicity of the enrolled participants.

To facilitate recruitment of AA individuals with MS into exercise training RCTs, and perhaps rehabilitation more broadly, the field requires greater awareness of the unique needs and preferences of the target population. This paper describes our experiences and lessons learned with outreach and recruitment strategies implemented in an ongoing RCT of a remotely delivered, culturally tailored exercise training program for AA persons with MS.

 We also report on the strategies that were most effective in screening and enrolling participants. These strategies may help future researchers recruit participants with MS from underrepresented populations into RCTs of exercise training and, perhaps, other rehabilitation research.

The Targeted Exercise for African-Americans with MS (TEAAMS) study examines the effects of a 16-week, remotely delivered, culturally tailored aerobic and resistance exercise training program compared with an active control condition (stretching and flexibility) for immediate and sustained improvements in walking and other outcomes among AA persons with MS located in the southern portion of the US. The primary outcomes are walking dysfunction, as measured by the Multiple Sclerosis Walking Scale (MSWS-12), and mobility disability based on the Patient-Determined Disease Steps (PDDS). Outcomes are assessed remotely via Qualtrics at baseline, immediately post intervention (4 months), and 4 months post intervention (8 months). The University of Illinois at Chicago (UIC) Institutional Review Board approved this study, and all participants provided informed consent before enrollment. The TEAAMS study protocol has been described fully elsewhere.

All participants were screened by the project coordinators (E.F. and D.G.) before entering the trial. The primary criteria for inclusion and exclusion are included in 

. Participants who satisfy the initial eligibility assessment complete a second screening on walking dysfunction (MSWS-12 score of 25-75 on a 100-point scale) and mobility disability (PDDS score of 2-6 on an 8-point scale).

The power analysis indicated enrollment of 80 participants (40 per group) to yield appropriate power for testing the time × condition interaction on the main trial outcome of walking impairment. The final enrollment goal is 100 participants (50 per group) based on an anticipated dropout rate of approximately 20%. The project is funded for 4 years, and the initial enrollment target was 5 participants per month over 20 months, with recruitment beginning in November 2022.

The sociocultural and historical factors surrounding the recruitment of underrepresented groups mentioned in the introduction influenced decisions about staffing, collaborators for recruitment efforts, and recruitment strategies. We began planning recruitment activities in July 2022 during a team meeting. The meeting included the study principal investigator (White male, Illinois resident) and co-investigator (White female, Alabama resident), project coordinator (Hispanic/Latino male, Illinois resident), outreach coordinator (Black female, Alabama resident), consultant (Black female, Michigan resident), and behavioral coach (Filipino female, Illinois resident). The principal investigator (PI; R.W.M.) described the purpose of the study, its eligibility requirements, and preliminary plans for recruitment (eg, development of a study name and logo). The group then brainstormed potential recruitment strategies and sources and discussed the rationale of our recruitment strategy (ie, existing health inequities among AA individuals with MS living in the southeast) and the logistics of virtual recruitment and outreach. We decided that study outreach activities to support participant recruitment would be performed by the University of Alabama at Birmingham (UAB) outreach coordinator (W.N.N.), under the supervision of the UAB-site PI (D.P.). The UIC would play a passive role in outreach and oversee participant screening, consenting, data collection, participant monitoring, intervention delivery, and data analysis and interpretation.

The initial and subsequent team meetings allowed for the development of an explicit marketing plan, discussion of logistics for participant screening and enrollment, and identification of additional recruitment sources, strategies, and methods. Participants would be recruited in groups or waves staggered at 4-month intervals, with the first wave of participants beginning the intervention in December 2022 and assessments for the final wave planned for November 2024. We aimed to screen 30 to 40 participants per wave and enroll 20 participants per wave for our sample size goal of 100 participants in 20 months.

Description of Our Original Outreach and Recruitment Strategy

Our outreach and recruitment strategy considered participant-level barriers for diverse populations, including lack of access to competent care, lack of awareness of clinical trial opportunities, mistrust, and systemic racism and discrimination. Because previous research suggests that AA individuals with MS are less likely to trust universities as sources of research information,

 the lead outreach coordinator did not share study information directly with AA individuals with MS. Instead, the original plan focused on a passive, indirect approach to recruitment in the form of virtual outreach to MS organizations, local experts in the disease area, trusted community leaders, and patient advocates. We anticipated initiating outreach and recruitment efforts one state at a time, starting with Alabama. See 

for an overview of the original recruitment strategy.

To ensure recognition of the TEAAMS study, a logo (

) was developed to be included on all study materials for project branding and recognition. We created a study website to provide a brief overview of the study, eligibility information, and contact details for the study team (https://projectteaams.ahs .uic.edu/). Program materials were modified to include culturally appropriate content based on formative feedback from a national sample of AA individuals with MS.

 The modifications included (1) images of AAs in the program manual, newsletters, and videos; (2) resources and tips that address culturally relevant barriers to exercise; and (3) inspirational quotes rooted in faith and/or well-known quotes.

Modifications of the Original Recruitment Strategy

We anticipated that most individuals would be recruited through the methods described in Table 1, yet regular engagement among the research team, feedback from trusted community leaders and patient advocates, and trial-and-error provided opportunities to improve the scope and effectiveness of outreach efforts through modifications to the original recruitment strategy. The recruitment and enrollment period was extended from 20 to 22 months (November 2022 to September 2024) due to a delayed intervention start by 1 month and the initial recruitment rate being slower than expected. After the first wave of participants, we modified our recruitment and enrollment timeline (ie, enrollment staggered at 4-month intervals with 20 participants per wave) so that subsequent waves began at 2-month intervals with 6 to 10 participants per wave. Outreach and recruitment efforts were expanded to include all states per wave and targeted Southern states (ie, Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, and Texas). After the initial months of recruitment, we shifted our focus from contacting churches and health ministries to partnering with other community organizations, such as public libraries; local and AA-owned newspapers; and AA civil, social, or fraternal organizations. Virtual, primarily passive, outreach efforts were broadened to include active strategies (eg, face-to-face engagement at local recreation or community centers, senior centers, health care facilities, schools, and community or health fairs).

Modifications to outreach and recruitment materials included: (1) creating a short video describing the study, which was provided to champions and change agents (eg, faith-based organizations, social media influencers, community organizations) for online sharing (see supplementary content); (2) updating email templates used to contact champions and change agents to increase response rates (eg, using lay language for support group leaders, defining MS for non–disease-specific organizations, personalizing to location, adding headshot to signature); (3) adding a prescreening form to the study website that allows interested individuals to be contacted by the study coordinator; and (4) revising the language on the study flyer to highlight the benefits of participating in the study and including a QR code to direct participants to the website and prescreening form (

As of February 2024, the outreach coordinators contacted 453 entities, including MS organizations, health care providers, community organizations, patient representatives, universities, and professional organizations. The response rates from the entities differed by category, with MS organizations (ie, National Multiple Sclerosis Society [NMSS], Multiple Sclerosis Association of America [MSAA], North American Research Committee on Multiple Sclerosis [NARCOMS], National African Americans with Multiple Sclerosis Registry [NAAMSR], Accelerated Cure Project [ACP], Multiple Sclerosis Views and News [MSV&N], and Multiple Sclerosis Foundation [MSF]) yielding the highest response rates. Those organizations supported our outreach efforts by sharing study information through emails, newsletters, and social media with registry members who met our basic eligibility criteria (ie, self-identify as Black or AA, live in 1 of the included states), or by providing direct access to self-help group leaders for further community outreach (MSF). Of the 24 directly contacted MSF self-help groups, 4 agreed to distribute study flyers, and 2 requested an information session. Both sessions were conducted via Zoom and included an introduction to general and MS-specific benefits of physical activity, recommendations for becoming and staying physically active, and an overview of the TEAAMS study, followed by a question-and-answer session. Additionally, the NMSS and MSV&N facilitated recruitment opportunities by inviting the lead outreach coordinator to local events (eg, fundraising walks, luncheons, and information sessions) to distribute TEAAMS study information. The NMSS also featured a blog post on their Momentum Magazine website describing how the TEAAMS study contributed to the need for more culturally competent research (https://www.nationalmssociety.org/news-and-magazine/momentum-magazine/research-and-science/breaking-the-cycle-of-exclusion). While few individually owned physical therapy clinics responded to our request to share study information with their clients, a partnership was established with a large physical therapy provider to distribute information to clinicians and patients at over 500 clinics throughout the South.

Of the 42 AA-owned newspapers contacted, one (

) published an article regarding the importance of exercise for AAs with MS and the TEAAMS study (https://tntribune.com/teaams-project-shines-light-on-ms-and-the-black  -community/). Surprisingly, focusing on predominantly AA churches and health ministries was one of the less effective outreach strategies. Only 3 of the 51 African Methodist Episcopal and Missionary Baptist churches contacted responded to our email and/or phone calls. The pastors agreed to share the study flyer with congregation members, though it was unclear if any members were diagnosed with MS. Other community-based professional organizations, including Black in Neuro, the National Black Nurses Association, and the Council on Black Health, played a supportive role by disseminating study information within their professional networks.

Although quantifying the exact impact of distributing letters and study flyers to over 164 public libraries and medical facilities within our target area is difficult, we know that at least 4 neurology clinics shared study information with patients, as evidenced by participants mentioning how they learned about TEAAMS. Other less frequent approaches include sharing study information via universities with established community networks and distributing flyers via community health workers. We explored using paid traditional advertisements (ie, television, radio, newspaper) but ultimately found these options to exceed our study’s budget constraints. Nevertheless, we allocated a small portion of the budget to collaborate with an ethnic disease-specific organization (We Are ILL) to distribute the study flyer to their existing member registry that contained over 1300 individuals.

As of February 2024, approximately 393 persons with MS have expressed interest in the study, and 354 (90.1%) were contacted by the project coordinator. Of the contacted individuals, 205 (57.9%) were scheduled for phone screenings, and 192 (54.2%) underwent eligibility assessments. Among those assessed, 88 were eligible for participation, and 8 declined to participate, resulting in the enrollment of 80 (41.7%) participants (

). Of the 104 individuals deemed ineligible for the study, the majority (71.2%) were excluded due to protocol-defined criteria associated with disease status and physical activity levels: 19 individuals (18.3%) did not meet the walking dysfunction criterion, 37 (35.6%) failed to meet both the ambulatory disability and walking dysfunction criteria, and 18 (17.3%) did not meet the physical activity, ambulatory disability, or walking dysfunction criteria. Two (1.9%) individuals were excluded based on not self-identifying as Black or African American, and 12 individuals (11.5%) were excluded as they did not self-identify as residing in the southern US.

Of the 393 interested participants, 268 (68.2%) completed the website prescreening form, and 111 (28.2%) contacted the project coordinator via email. Other initial contact methods included phone calls (n = 28, 7.1%) and referrals from neurologists (n = 6, 1.5%), with some potential participants utilizing multiple contact methods.

Recruitment methods for 40.1% (n = 77) of the 192 participants assessed for eligibility were identified (

). The yield varied by recruitment method, with referrals from disease-specific organizations (eg, NMSS, NAAMSR, ACP, MSAA, We Are ILL, and MSF newsletters) being the most effective (n = 50, 64.9%). Other effective recruitment methods included referrals from MS organization–affiliated support groups (n = 7, 9.1%) and virtual platforms, such as websites, Facebook, and disease-specific podcasts (n = 11, 14.3%).

This paper describes participant recruitment strategies implemented for a remotely delivered, culturally tailored exercise training program for AA individuals with MS and provides a resource for future researchers conducting inclusive rehabilitation research with underrepresented populations. Although the trial is ongoing, the TEAAMS study implemented a multipronged approach to recruitment that involved primarily passive outreach strategies to achieve 88.9% of our recruitment goal after 15 months (80 enrolled participants divided by 90 expected eligible and enrolled by February 2024).

Most participants (64.9%) were recruited via MS organizations, in line with a previous exercise training intervention for persons with MS.

 Although recruitment data were not available for most screened participants (60%), noticeable increases in interest were observed following the inclusion of study information in MS organization newsletters. A recent study indicated that MS organizations and MS websites/blogs were the top 2 sources for research information reported by people with MS, with no differences between racial and ethnic groups.

 Awareness of MS in AAs has prompted disease-specific organizations to provide more resources and programs catered to this segment of the MS population, likely contributing to increased response rates. Moreover, the variety in how participants learned of the study highlights the necessity for variable recruitment strategies. For instance, 7 individuals assessed for eligibility learned about the study from 1 of the 6 support groups that agreed to distribute our flyers.

Initial recruitment progressed more slowly than expected, but we ultimately achieved an average monthly enrollment rate of 5.3 participants. While seldom detailed in existing literature, this metric surpasses the enrollment rate of a comparable large-scale MS exercise trial, which reported 3.5 participants enrolled per month

; however, this study required regular in-person attendance, unlike our home-based training program. Physical activity and exercise training interventions involving other populations, such as AA women living in Alabama and older AA breast cancer survivors, have reported similar enrollment rates at 7.0 per month

 respectively, suggesting that our recruitment rate is a realistic target for future remote exercise training interventions for AA adults with MS.

Matching the race of the research staff with the desired participants is beneficial to study recruitment and retention

; other factors such as class, education, personality, and shared values may also influence the recruitment of AA individuals into clinical trials.

 Our study team was intentionally diverse across these dimensions to foster recruitment of a more diverse study sample. The lead outreach coordinator (W.N.N.), a lifelong resident of the AA community in Alabama, leveraged personal experiences and local knowledge to effectively support TEAAMS study recruitment. Team members, including consultants and coordinators, came from other underrepresented backgrounds, sharing similar knowledge and values. We strongly suggest that future research teams mirror the diversity, values, and experiences of the underrepresented communities they seek to engage in their recruitment efforts.

Multipronged, Nontraditional Recruitment Strategies

The development of our comprehensive, multifaceted recruitment and engagement plan aligns with recommendations to diversify clinical trials for people with MS.

 Our approach combined 7 passive strategies, from traditional partnerships with MS organizations to engaging local libraries and ethnic organizations, which is more than the reported 5 strategies utilized in previous MS research studies.

 Multiple passive, nontraditional approaches, such as engaging with nonspecialist community providers, local community agencies, and patient partners, were effective for identifying AAs with MS living in the South.

The study’s unique structure, with the lead site (UIC) in a supportive role and UAB directing outreach, enhanced recruitment efforts. This is similar to other studies using institutional support to reach underrepresented groups.

 The lead study site’s management of enrollment activities allowed the lead outreach coordinator to develop innovative recruitment materials and quickly pivot to integrate active outreach strategies. Although direct impact is challenging to quantify, this focused approach to outreach and engagement facilitated the identification of nearly 500 potential collaborators.

Weekly videoconferences with the research team identified recruitment challenges and devised timely solutions. This adaptability led to the development of improved strategies for identifying potential participants. For instance, to counter recruitment slowdowns, we broadened our outreach to include local event attendance, which enhanced connections with disease-specific organizations, maintained study visibility, and uncovered new opportunities for support and recruitment.

Study Website and Online Prescreening Form

A prescreening form on the study website (https://projectteaams.ahs.uic.edu/) emerged as the top method for potential participant contact, with 68.2% using this method to indicate their interest. All recruitment materials, such as flyers and information in organizational newsletters, directed individuals to the study website, which explained the TEAAMS study in lay language, alongside details about the research team and online interest form (hosted via Qualtrics). Given the extensive online presence of MS resources,

 the large number of potential participants recruited via the website prescreening form suggests that this may be an effective strategy for increasing research engagement among AAs with MS.

Despite previous research suggesting that faith-based settings could effectively recruit AAs into clinical research trials,

 our outreach attempts had limited success. Fewer than 6% of the African Methodist Episcopal and Missionary Baptist churches we contacted responded to our emails and/or phone calls, leading us to refocus our outreach efforts toward other community organizations, such as public libraries and local and AA-owned newspapers. The lack of success with churches might stem from relying on passive outreach methods without first establishing rapport with church leaders and members. In contrast, previous research suggests that a prior working relationship with churches may play a role in recruitment success,

 highlighting the importance of fostering relationships with the churches before requesting recruitment assistance.

This study is not without limitations. Notably, we could only trace the enrollment source for 40.1% of participants. This gap stems from the omission of a referral question in the screening form; the coordinator collected such details post screening. Future research should include referral tracking in initial questionnaires to gauge recruitment strategy effectiveness. In addition, fewer than half of the participants assessed for eligibility were enrolled in the study, with reasons for ineligibility primarily related to not meeting inclusion criteria for walking dysfunction. Eligibility of interested participants may have been further limited by our requirement for internet access. Lastly, the focus on AA individuals with MS in the southern US likely limits the applicability of these results to other regions.

This paper highlights the importance of a flexible, comprehensive, multifaceted plan for recruitment and engagement of AAs with MS in exercise training RCTs. Despite the effectiveness of referrals from MS organizations, the diversity of how participants learned about the study showcases the success of integrating multiple traditional and nontraditional approaches. To our knowledge, this is the first paper to report recruitment strategies in an exercise RCT specifically for AAs with MS, offering a framework for future research to incorporate underrepresented groups in exercise RCTs and perhaps broader rehabilitation studies.

Recruitment of African American Adults With Multiple Sclerosis Into Randomized Controlled Trials of Exercise Training: Lessons Learned From Project TEAAMS

To improve the quality and standard of care, considerable resources are invested to produce clinical guidelines for multiple sclerosis (MS) management. We aimed to investigate MS clinicians’ use of guidelines and factors that influence use.

Interview guides were developed using Fisher’s framework to assess factors that influence guideline application (categorized as personal, guideline related, and external). Nurses and neurologists experienced in MS health care were recruited through convenience sampling. Semistructured online interviews were conducted from June 2023 to October 2023, and data were analyzed using inductive and deductive methods.

We interviewed 16 MS clinicians (10 nurses, 6 neurologists). Despite most clinicians believing that guidelines can improve consistency, safety, and quality of care, the application of guidelines was highly variable. Participants reported that clinical decision-making in MS management involves integrating guideline recommendations with clinical reasoning while considering patients’ circumstances and preferences, the complex nature of MS, and resource constraints. Personal barriers to guideline application included low awareness and familiarity. Guideline-related barriers included evidence, plausibility, accessibility, layout, and complexity. External barriers included a lack of resources. Facilitators were mostly guideline related, including relevance to local protocols, covering complex treatment or unfamiliar topics, and when guidelines were up to date and credible. Participants suggested various strategies to overcome barriers to guideline use.

Australian MS clinicians reported low awareness and high variability in the application of national and/or international MS guidelines. Clinical practice guidelines should be adaptable to local contexts, accessible, and regularly updated. Multifaceted strategies to better distribute and champion guidelines should be employed.

From the Disability and Health Unit, The Melbourne School of Population and Global Health (IW-B, CHM) and the Melbourne School of Health Sciences (MK), The University of Melbourne, Melbourne, VIC, Australia; the Discipline of Exercise Science (YCL) and the Personalised Medicine Centre, Health Futures Institute (YCL, AK), Murdoch University, Perth, WA, Australia; Perron Institute, University of Western Australia, QEII Medical Centre, Perth, WA, Australia (YCL, AK); Health and Social Care Unit, the School of Public Health and Preventive Medicine (DA) and Alfred Health (JH), Monash University, Melbourne, VIC, Australia; School of Medical, Indigenous and Health Sciences, University of Wollongong, Wollongong, NSW, Australia (YP); and the Institute of Neuroimmunology and Multiple Sclerosis Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (CH).

 Claudia H. Marck, The University of Melbourne, Grattan Street, Parkville Victoria, 3010, Australia; 

Yasmine Probst and Darshini Ayton declare that they are people living with multiple sclerosis (MS). Claudia H. Marck, PhD, was funded by a University of Melbourne Momentum fellowship and an MS Australia fellowship (20-216). Yvonne C. Learmonth was funded by an MS Australia fellowship (21-3-053) and the Western Australia Department of Health (WANMA EL 2022). Darshini Ayton is funded by a National Health and Medical Research Council Emerging Leader 1 fellowship (2021-2025; APP1195357). Yasmine Probst was funded by an MS Australia Senior fellowship (21-3-014). All other authors declare no competing interests.

Management of multiple sclerosis (MS) is complex and requires multidisciplinary care. Over 33,000 people live with MS in Australia, and the prevalence is increasing faster than population growth.

 However, although the standard of medical care is generally high in Australia, recent reports conclude that the standard of MS care is variable and impacts health outcomes. For example, 31.5% of people living with MS in Australia lack access to a specialist MS nurse, which is associated with worse health outcomes.

 Further, MS care provision in the Australian Capital Territory was reported to be fragmented, below the standard of recommended care, and lacking multidisciplinary integrated care.

 Other reports of inconsistencies or gaps in MS care include family planning,

 and referral to allied health for symptom and comorbidity management.

 These findings are in line with those of a large study that found that Australian adults received appropriate evidence-based health care in only 57% of health care encounters.

Opportunities to improve the standard and quality of care should be identified to ensure optimal outcomes and health equity for all Australians living with MS. Clinical practice guidelines (hereafter, 

) are designed to improve and maintain standards, effectiveness, and consistency of care; reduce inappropriate care; and reduce geographic variations and other inequities.

 High-quality guidelines are based on rigorous syntheses of best available evidence and expert consensus to support clinical decision-making. The application of guidelines should be viewed through the lens of comprehensive clinical decision-making, considering elements such as professional expertise, patient preferences, and practical feasibility.

The acceptability and uptake of guidelines among MS clinicians remain unclear in Australia, and only limited data exist globally. One Australian study assessed compliance among radiologists with the 2003 Consortium of Multiple Sclerosis Centers MRI diagnostic protocol and found incomplete compliance, potentially leading to incorrect or delayed diagnosis.

 Results from 2 German studies found that although there was an overall high level of agreement among 327 neurologists with the German MS treatment guidelines, many considered them too prescriptive and conservative.

 Findings from a 2024 study identified a large gap between the international MS Brain Health quality standard and its real-world adaptations among 71 German neurologists, many of whom reported that the standard was too ambitious, mostly due to a lack of resources.

Although barriers to MS guideline application are largely unknown, from other clinical areas, we know that barriers are commonly clinician related (such as lack of awareness, agreement, self-efficacy, outcome expectancy) or related to organizational factors such as lack of time and resources.

 Guideline-related barriers are also commonly reported, including shortcomings in validity, format, accessibility (eg, paywall, language barrier), credibility, and usability or specificity.

 Our review of 31 guidelines regarding complementary therapies in MS showed variable methodological quality,

 which may lead to suboptimal implementation. In addition, our systematic review of 19 physical activity guidelines for application by MS clinicians showed that these guidelines rarely specify the actions that clinicians should take, likely hindering application.

 Understanding barriers and facilitators to guideline application is the first step to creating strategies to improve guideline implementation and, ultimately, health outcomes.

Therefore, this study aimed to investigate the extent to which MS clinicians apply treatment guidelines and the barriers and facilitators to application. The study is underpinned by Fisher’s framework, designed to assess factors influencing guideline application, which includes 3 domains: personal/clinician factors, guideline-related factors, and external factors.

This study was a cross-sectional qualitative exploration using online semistructured interviews. The interview guide (See 

which is included as a PDF at the end of this article.) was informed by Fischer et al’s framework,

 tested for content and construct, and refined iteratively by the research team that included clinicians, researchers, and people with lived experience of MS (n=9). Ethics approval was obtained through the University of Melbourne Human Research Ethics Committee (Ethics ID 2023-26508-41004-3). We report our findings using the Consolidated Criteria for Reporting Qualitative Research checklist.

Interviews were conducted by 1 of 3 researchers (I.W-B., junior medical doctor and researcher, female; C.H.M, researcher, female; and Y.C.L, researcher and physiotherapist, female) with relevant training and experience in interviewing for clinical practice and/or qualitative research. There was no established relationship between the interviewer and any participants, and participants did not have knowledge about the interviewer that may have impacted the interview. Although several authors have previously been involved in developing guidelines for MS management, none have any competing interests or biases relevant to this work.

MS clinicians were eligible to participate if they were neurologists or MS nurses currently delivering or overseeing health care for people with MS in Australia in a public and/or private capacity. The sample represents the main clinician groups who deliver MS care in Australia and are the primary target audience of most MS guidelines. Participants were recruited through convenience sampling, including direct emails to clinicians and MS clinics, newsletters and websites of professional bodies and MS societies, online social media, professional contacts of our research team (via email or verbal invitation), and snowballing recruitment.

Researchers conducted one-to-one, semistructured 20- to 40-minute interviews online between June 2023 and October 2023. Interviews were conducted and recorded using an online platform (ie, Zoom or Microsoft Teams, depending on participant preference). Verbal informed consent was obtained at the start of each interview. Transcripts were not returned to participants for comment, but participants were asked to email the interviewer if they had any additional thoughts.

Data were analyzed using an iterative deductive-inductive thematic approach.

 An initial coding tree was created a priori based on the framework by Fischer et al,

 with theme descriptions clarified by Cabana et al.

 Data were first coded deductively according to Fischer et al’s framework and further coded as barriers, facilitators, or preferences and needs. Inductive coding was then performed to create new codes for emerging themes and delete irrelevant codes. Two researchers (I.W-B., C.H.M.) independently coded 3 transcripts, discussed discrepancies to reach consensus and ensure reliability, and then consulted with a third researcher (Y.C.L.) to reach agreement on the draft coding structure. One researcher (I.W.B.) coded the remaining transcripts. We integrated the deductive and inductive coding to identify final themes (

). Exemplar quotes are provided with the participant’s profession and years in specialist practice. Data were managed using NVivo 14 (QSR 14.24.0, 2023).

We interviewed 10 MS nurses and 6 neurologists from public and private settings (11 women and 5 men); 10 had 10 or more years of neurology specialty experience (

 to describe both formal resources developed by a professional body or group of experts (external guidelines) and local hospital or clinic protocols (internal guidelines). The application of external guidelines was highly variable among clinicians and generally lower among neurologists compared with nurses, whereas internal guidelines were more widely used. Barriers and facilitators to guideline application are summarized below and in 

lists strategies proposed by participants to overcome commonly identified barriers.

Awareness and familiarity with guidelines. 

Clinicians were familiar with internal guidelines and protocols produced by their organizations. Most clinicians were also aware of guidelines produced by recognized bodies such as the United Kingdom’s National Institute for Health and Care Excellence (NICE), the Brain Health Initiative, the American Academy of Neurology, and Australian guidelines for treating MS during the COVID-19 pandemic, which were produced by a team of Australian and New Zealand neurologists.

 Clinicians often read new external guidelines at the time of publication, but they rarely returned to them and could not recall specific content, resulting in low familiarity, a major barrier to guideline application (quotations associated with clinician-related factors are available in 

). Experienced clinicians frequently reported relying on their clinical acumen rather than a particular guideline. Inversely, clinicians often reported using guidelines when faced with an unfamiliar or complex clinical scenario or if they did not manage many individuals with MS.

Despite generally agreeing with guideline recommendations on clinical practice, clinicians consistently expressed a strong desire to reserve autonomy in their practice and adapt recommendations to their patients’ contexts and preferences. If clinicians disagreed with the content of the guidelines, this was a strong barrier to application. Disagreement with guideline recommendations was often contextualized within the broader lack of consensus among neurologists, which was attributed to limited data and clinician differences in risk management.

 Most clinicians agreed that guidelines improve patient outcomes and clinical practice. Nurses often remarked that both internal and external guidelines could ensure standard of care, improve consistency in practice, be a part of practice review, provide a foundation on unfamiliar topics, reassure that your practice is evidence based, help with busy workloads, keep all providers up to date, and increase generalists’ comfort levels with the delivery of new therapies. These practice improvements were broadly thought to lead to higher quality care and better safety and health outcomes for patients. However, some neurologists were concerned that when guidelines are out of date or overly conservative, this may adversely affect patient outcomes; this was cited as a major barrier to implementation.

Most clinicians regarded guidelines produced by well-known professional bodies (eg, MS Australia, NICE) as evidence based, which they identified as a facilitator to guideline use.However, clinicians noted variation in reporting of levels of evidence in guidelines, leading to skepticism in the development process, a barrier to adoption(quotations associated with guideline-related factors are available in 

Clinicians perceived external guidelines as often out of date given the fast-moving pace of MS research, particularly in relation to disease-modifying therapies (DMTs)

However, some neurologists trusted that guidelines developed by reputable organizations have established processes for regular (ie, at least annual) updates. Published updates of guidelines were perceived to prompt discussion within clinical teams.

. Clinicians generally attributed trustworthiness to guidelines developed by appropriate experts, including neurologists, nurses, pharmacists, allied health providers, and consumer organizations. The aforementioned COVID-19 guidelines were quoted as an example of highly trustworthy and plausible guidelines. Endorsement and/or promotion of guidelines through reputable organizations also bolstered clinicians’ confidence in their validity and facilitated application.

Most neurologists expressed major concerns that DMT recommendations in international guidelines may be influenced more by health care funding than by evidence on patient outcomes, reducing clinician confidence in them. In addition, some believed guideline producers were reluctant to favor certain pharmaceutical companies over others. These concerns were major barriers to guideline application.

Clinicians noted that long, complex documents were often impractical given the practice time constraints; they preferred brief and digestible documents, checklists, and visual aids to facilitate day-to-day application. Most participants said guidelines do not need to consider comorbidities; this is a role for the clinician when interpreting the guidelines.

 Clinicians commonly reported difficulties in accessing MS guidelines due to their dispersion across multiple platforms as well as restrictions imposed by paywalls and login requirements; these were a major barrier to application. At the time of the interviews, clinicians cited helpful guidelines on topics such as treatment initiation, management and monitoring of infusion therapies, acute therapy for relapses, some symptom management, and new and evolving topics such as COVID-19. Clinicians reported a lack of available guidance on DMTs during pregnancy and breastfeeding; management of primary progressive MS; treatment cessation; stem cell therapy; emotional well-being; and management of pain, fatigue, cognition, and continence as common yet complex symptoms requiring individualized treatment.

Many clinicians were cautious about using external guidelines from countries other than Australia. Clinicians consistently expressed the need for local area-specific guidelines due to differences in funding, medications, resources, and available services across countries. Most participants reported the application of internal guidelines and protocols because they are often adapted from external guidelines to be more relevant to the local health context by groups they trusted to be up to date. Clinicians expressed a need for guidelines to include actionable recommendations or links to services and/or resources.

 A cohesive guideline for all MS clinicians, including neurologists, MS nurses, and allied health providers, was seen as a crucial facilitator to providing comprehensive and consistent care. Clinicians also noted that guidelines could be particularly useful for clinicians who do not frequently treat people with MS as well as for junior clinicians. Some clinicians stated that general practitioners should also have guidelines that are relevant to their scope, due to access barriers to MS neurologists in some areas of Australia.

 Clinicians often found that guidelines were applicable to most people living with MS, but they still emphasized the need to tailor recommendations to each patient. This was especially prominent when it came to family planning and lifestyle or health behavior. Having guidelines available for patients (eg, handouts) aided consistent messaging and combated misinformation. Several clinicians noted the heterogeneity of MS disease course and symptoms as a barrier to development and application of guidelines. Some clinicians noted that the complexity of MS management has gone up exponentially and that there has been a shift toward “living well with MS” but the resources have not kept up.

Clinicians regularly spoke positively about the freedom they have in Australia when it comes to prescribing high-efficacy DMTs. The mandated guideline compliance and restrictions on prescribing in some other countries were thought to hinder best practices and patient outcomes (see 

). However, it was also reported that limited access to an MS nurse specialist impacted best care.

Workplace resources, policies, and procedures. 

Several clinicians reported that team-based practice and multidisciplinary teams included MS nurses as facilitators to guideline application; these accommodations are often facilitated in the public sector but not in private practice. Having internal guidelines available and being involved in a regular review process kept clinicians up to date. Automated reminders generated by hospital systems to review guidelines and policies were reported as helpful.

Lack of resources, which translated into time pressure and staff shortages, resulted in difficulty meeting target time frames set by guidelines. In particular, the inequitable access to resources between clinics, especially in the geographical context of Australia, was highlighted frequently as a barrier to meeting guideline recommendations. Time was repeatedly discussed as the major barrier to guideline application; however, some clinicians also mentioned that if optimized, guidelines could make clinical practice more time efficient

There was little mention of formal training on guideline application. Clinicians were receptive to educational workshops and conferences or incorporating further guideline education into journal clubs and unit meetings.

 Rather than relying on guidelines, clinicians turned to their colleagues and wider professional networks for information sharing and/or news and guidance. Working with a larger team meant they were more likely to hear about guideline updates through colleagues. Collaboration was therefore described as both a barrier and a facilitator to guideline application.

Most clinicians reported a working culture that is open to guidelines, where clinicians share them and consider integrating the recommendations into their practice, but some reported that guidelines are not promoted. Rather, clinicians reported that practice is commonly determined by the senior medical consultant. They acknowledged that this leads to between-clinic variability in how people with MS are treated. This practice was reported as being particular to MS management, whereas practice in other neurological diseases or other specialties is thought to be more closely directed by guidelines. The trend in guideline application over time is unclear; some say that there are more guidelines available and more clinicians using them, but others say that they have not noticed trainees using them any more than consultants.

Our qualitative study results show that the application of MS management guidelines among Australian clinicians varies widely. Preference was given to using internal (hospital/clinic) guidelines, followed by Australian guidelines, over international guidelines due to differences in resources and available treatments and services across countries, influencing applicability. Barriers to applying evidence-based treatment guidelines were mostly related to the guidelines themselves, followed by clinician-related barriers; a few external barriers were also reported.

Although many clinicians were aware of national and international guidelines, they were not overly familiar with their content. There was overall agreement that guideline application improves the consistency, safety, and quality of MS care (more pronounced among nurses than neurologists) but that guideline application should be considered within the broader context of clinical decision-making. Some neurologists with decades of clinical experience reported that they do not apply external guidelines at all but rely on their clinical acumen. This selective uptake, especially by experienced clinicians, has been reported previously in countries where guidelines are not mandated.

 Others commented that guidelines provide an opportunity to integrate new evidence into practice and reduce the risk of outdated or biased decision-making. Most clinicians reported a working culture that is open to guideline application. However, it was also commonly reported that the senior medical consultant sets the direction in terms of treatment patterns, leading to variability in MS care between clinics or hospitals. Inequities in MS care between clinics or geographical areas have been investigated and reported on in the United States and Canada and are shown to impact health outcomes.

 Research from the United Kingdom showed DMT prescribing differences between neurologists due to variability in familiarity with the drugs and their perceived risks as well as organizational and peer network cultures; the conclusion was that more needs to be done to achieve equity in MS care.

Our participants voiced substantial criticism of international DMT prescribing guidelines. A common argument was that these guidelines did not have best outcomes for patients at their core but may instead have been driven by economic factors (ie, conservative DMT management to keep costs down). Another concern was that they were influenced by pharmaceutical companies (ie, reluctance to strongly favor some DMTs over others). These concerns are in line with findings from Germany

These concerns may reflect a change in the field that is moving away from the treatment escalation paradigm (initiation of a moderately effective DMT and, if needed, escalating to a more efficacious DMT with potentially higher risks) toward the early intensive/aggressive (initiation of high-efficacy DMT early) approach.

 As the long-term benefits, risks, and costs of this approach are somewhat unclear, several treatment prescribing guidelines continue to recommend the escalation approach. However, the clinicians in our study were widely supportive of the early intensive approach, in line with the literature

 and with recently published Australian guidelines.

 Clinicians appreciated the absence of mandated prescribing guidelines in Australia; in contrast, neurologists from the United Kingdom reported feeling restrained by mandated NICE guidelines.

 Further, there were concerns that guidelines (especially regarding DMTs) were at risk of being outdated quickly. Suggestions were made that guidelines that using a living evidence approach for rapid updates when new evidence is published could negate this issue. This approach has been shown feasible and acceptable in stroke management

Several areas that lacked guidelines were identified (family planning, primary progressive MS, treatment cessation, stem cell therapy, emotional well-being, management of pain, fatigue, cognition, and continence), although some relevant guidelines were published after our data collection.

 Strategies to overcome the most common barriers identified in our study include ongoing promotion and distribution, educational initiatives, endorsement by leaders and professional bodies, demonstration of improved patient outcomes, use of best practices for guideline development and regular updates, stakeholder involvement, area-specific guidelines, demonstration of accessibility and usability, and a centralized guideline library (Table 4).

Our multidisciplinary team included people with lived experience of MS, clinicians, and researchers, most of whom have contributed to MS guideline development; this strengthened the development of the interview guide and the interpretation of our findings. This is an important first step to understand and improve the implementation of guidelines to improve clinician application, given the lack of data in this area. Limitations of this study include the small sample size and use of convenience and snowball sampling; however, the convergence of themes across the interviews, the international literature included, and the diverse roles of the respondents increase our confidence in the results. Our study focused on Australian MS clinicians, which may limit generalizability to the international community.

The outcomes of our study may inform future development and implementation of guidelines, with the aim of improving standards and equity in MS care. Guidelines are often simply released (eg, via journal publications) but not implemented.

 Our study is especially pertinent given the recently published guidelines for MS management in Australia, which included 80 recommendations, a large collaborative effort from MS clinicians with input from a range of stakeholders.

 Significant resources go into developing guidelines, and their appropriate implementation ensures a return on resource allocation. Further, access to Australian health care is fragmented and poor for segments of Australian society,

 and guidelines have the potential to play a role in reducing inequities.

Guideline developers, health care organizations, professional bodies of clinicians, and clinicians caring for people with MS can use the strategies we identified (Table 4), combined with the literature on guideline implementation,

 to work together to better implement where appropriate. These strategies can be effective to improve practice and patient outcomes; however, heterogeneity and gaps in evidence remain.

 Further studies should investigate whether these strategies lead to (1) a change in MS clinician practice, (2) improved health outcomes for people with MS, (3) reductions in inequities in MS care and health outcomes, and/or (4) health care efficiencies and cost savings.

The results of our qualitative study found that the application of national or international MS treatment guidelines among MS clinicians in Australia was generally low. We identified barriers and facilitators to guideline application with associated strategies to improve guideline implementation. With considerable resources invested in the development of high-quality and evidence-based guidelines, improving implementation has the potential to reduce variability in treatment quality and advance standards and equity of MS care through more comprehensive and contemporary care.

The Application of Treatment Guidelines in  Multiple Sclerosis Care: A Qualitative Analysis of Barriers and Facilitators

Author Katherine Knox, MD, FRCPC, was the first author of 

Physical Activity in Multiple Sclerosis: Real-World Data From Saskatchewan, Canada

International Journal of Multiple Sclerosis Care

Knox is an associate professor in the University of Saskatchewan's Department of Physical Medicine and Rehabilitation, as well as the provincial department head. She is also a clinical investigator with the Cameco MS Neuroscience Research Center at the University of Saskatchewan and the MSCanRehab Network, with a focus on gait, exercise behavior, long-term outcomes, and quality of life for people with multiple sclerosis. Her clinical practice includes neurorehabilitation services, with a special interest in multiple sclerosis. Her fellowship training was done in physical medicine and rehabilitation at the University of Saskatchewan in the mid-2000s, and her degrees were completed at McMaster University. 

recently to discuss the approach to the paper and its findings, her career path, and her research.

: Tell us the story of this paper. Where did the idea come from, and how did you form the team of authors?

 The story actually started [with] Dr Walter Hader Sr. He established one of the first multidisciplinary clinics in Canada back in the 1970s, and he was meticulous with data collection, real-world data collection. Then, in 1997, when we were able to access Betaseron—the first disease-modifying [DMT] treatment for MS [multiple sclerosis]—in Saskatchewan, the minimum data set expanded and an infrastructure for real-world data collection was set up in partnership with the Ministry of Health.

Because of that long-standing partnership and infrastructure, when the first 

 were published in 2013, [they] allowed us to fairly quickly add physical activity data to the data that we were collecting in a real-world setting of people accessing disease-modifying therapies in Saskatchewan. Those first guidelines for physical activity in MS were published by Amy Latimer and Kathleen Martin Ginis and [their] team. We decided to add the Godin Leisure-Time Exercise Questionnaire to collect physical activity behavior data.

It was pretty easy to bring the team together because we had some people who were really interested in MS here at the University of Saskatchewan. [Charity] Evans completed her postdoc at UBC [University of British Columbia] in MS pharmacoepidemiology, and she had joined [the] faculty, so she was a natural fit to join the team and help us analyze these real-world data, along with Sarah Donkers, who completed her PhD in exercise behavior and people living with MS at the University of Saskatchewan, so she was also a natural fit. And then we reached out to the Clinical Research Support Unit for some statistical support for the analytical portion, and we were really pleased to have a great team that joined us, along with a master’s [degree] student from their group. So that’s how the team came together, and that’s how the story started.

: What about this research was surprising to the team of authors?

There were actually 3 things that surprised me. The first is that we did not observe a statistically significant trend in physical activity levels over the 7-year data collection. The second was that prior DMT exposure was not associated with physical activity levels, and we had hypothesized that it might be. And the third was that there was quite a bit of fluctuation year to year in the proportion of people who met the threshold of activity level [that was] significant for substantial health benefits.

From all three of those points, I think there are some take-home messages. The first is this difference between statistical significance and clinical significance. Although we didn’t see a statistically significant finding, we did see that the physical activity levels are trending in the right direction. Over the 7-year span, it would be an average of about an additional 15 minutes of moderate physical activity over the course of a week. It’s not going in the wrong direction, which is good.

In terms of the fact that prior DMT exposure was not associated with physical activity levels, I think this is really important, because when people start a disease-modifying treatment, they’ve had a touch point with the health care system. They’ve had an opportunity for us to at least screen and try to intervene with health behavior modification. One would hope that if they touch the health care system for their DMT treatment, they’ve also had an opportunity to address their health behaviors, and we did not find that to be the case. So that’s really an opportunity there.

The third point is the fluctuation year to year in terms of the proportion of people who were not significantly active for health benefits: We saw quite a large variation, between 35% to 60% year to year. I think it just highlights the point that you can see variability year to year, and if you only have several points or time points of data collection, you don’t get an idea of what’s happening over time. You need that prolonged period of time to see if there are changes in behavior in real-world data. Those were 3 things that stood out for me.

: Do you have any comment on the difference between the physical activity recommendations vs your findings with the real-world implications? Why is there a disconnect there, that people with MS and clinicians aren’t acting on the recommendations?

Recommendations are important. We did see, right after the recommendations were published—in the year following—we did see a little blip, or a little increase. But then it wasn’t sustained. Whether that was associated with that publication or not, we can’t tell, but I think the point is that we need more than recommendations. We also need the infrastructure to implement the recommendations, which is really critical. The 

2020 updated physical activity recommendations 

IJMSC Author Spotlight shines a light on the people behind the research.

Nina Thomas, MPH

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